Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID

63396

Product Type

Devices

Status

Ongoing

Recalling Firm

OrthoPediatrics Corp

City

Warsaw

State

IN

Country

US

Voluntary/Mandated

Voluntary: Firm Initiated

Recall Initiation Date

2012-09-13

Initial Firm Notification of Consignee or Public

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.